Gentium Withdraws New Drug Application for Defibrotide. Nymox Updates Phase Three Pivotal Trials For NX-1207. Print E-mail
By Staff and Wire Reports   
Wednesday, 17 August 2011 18:47
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 17, 2011.

Gentium S.p.A. (NASDAQ:GENT) announced it has voluntarily withdrawn the New Drug Application (NDA) for Defibrotide following recent correspondence from the FDA identifying numerous 'Refuse to File' issues regarding the Company's NDA submission.

In their initial review, the FDA raised concerns regarding the completeness of the datasets for both the treatment and prevention studies. The FDA requested that the Company conduct additional quality reviews of the original datasets and databases. The FDA also requested additional details regarding the conduct and monitoring of the trials by the independent review committee.


Nymox Pharmaceutical Corporation (NASDAQ:NYMX), provided an update on the Company's Phase three pivotal trials for NX-1207, Nymox's investigational drug for benign prostatic hyperplasia (BPH).

The Safety Monitoring Committee meeting of August 16, 2011 was favorable and indicated no significant safety concerns for the two pivotal U.S. trials to date. Patient recruitment and trial activities for pivotal U.S. studies NX02-0017 and NX02-0018 are proceeding well at over 70 well-known urology investigative sites throughout the U.S. NX-1207 has been shown to improve the signs and symptoms of BPH, producing improvements which reached statistical significance compared to double-blinded placebo and study controls. A single administration of NX-1207 2.5 mg has produced on average improvements in the standardized BPH symptom score (8-10 points at 90 days) that were approximately double that reported for currently approved BPH drugs (3-5 points).

The drug is administered by a urologist in an office setting and involves little or no pain or discomfort. NX-1207 has not been found to have the sexual, blood pressure, or other side effects of the approved drugs. Follow-up studies have shown clinical efficacy effects in many men lasting up to 7 1/2 years after a single treatment.

Also Wednesday:

AdCare Health Systems, Inc. (NYSE Amex: ADK), a leading skilled nursing and assisted living provider, is exercising its option to call for redemption 100% of the outstanding warrants to purchase shares of common stock sold in its initial public offering in November 2006 and those sold in a private placement in December 2009.

BioDrain Medical, Inc. (OTCBB: BIOR) (OTCQB: BIOR), producer of the FDA cleared Streamway® System for automated surgical fluid disposal, today announced that Alan Shuler, the Company's Secretary and Acting Chief Financial Officer, will present details of the Company's growing commercialization at the National Investment Banking Association (NIBA) Conference being held at the Omni Parker House in Boston on August 17-19, 2011.

Celsion Corporation (NASDAQ: CLSN), a leading oncology drug development company, announced today the publication of a clinical and scientific review of ThermoDox®, the Company's proprietary heat-activated liposomal encapsulation of doxorubicin, as a treatment for Hepatocellular Carcinoma (HCC or primary liver cancer) in the August 2011 issue of Future Oncology (Volume 7, Number 8).

Hadasit Bio-Holdings, Ltd. (OTCBB: HADSY), a publicly traded portfolio of biotech companies, all based on intellectual property developed by the Hadassah University Hospital, Israel's foremost medical research center, announced that its portfolio company Enlivex Therapeutics (92% owned by Hadasit Bio) has completed the recruitment of three out of four groups in its Phase I / II clinical trial using its treatment for the reduction of graft versus host disease (GVHD) in patients undergoing bone marrow transplantation.

MELA Sciences, Inc. (NASDAQ: MELA) issued the following statement regarding the U.S. Food and Drug Administration's (FDA) draft guidance on Design Considerations for Pivotal Clinical Investigations for Medical Devices, including those conducted to support Premarket Approval (PMA) applications.

PAREXEL International Corporation (NASDAQ:PRXL), a leading global biopharmaceutical services provider, has been named Company of the Year for the Pharmaceutical Industry in The Eighth Annual International Business Awards, the only global, all-encompassing business awards program honoring great performances in business.

Protalix BioTherapeutics, Inc. (NYSE-AMEX:PLX, TASE:PLX), announced today that the U.S. Food & Drug Administration (FDA) has accepted for review the resubmission of the taliglucerase alfa New Drug Application (NDA) following the Company's receipt of a Complete Response Letter (CRL) in February 2011.  

Regeneron Pharmaceuticals, Inc. (Nasdaq:REGN) today announced that clinical data from four separate clinical studies of EYLEA™ (aflibercept injection) will be presented at the upcoming American Society of Retina Specialists (ASRS) meeting on Sunday, August 21 and Monday, August 22, 2011 in Boston, Massachusetts.

Stellar Pharmaceuticals Inc. (OTCQB:SLXCF) ("Stellar" or "the Company"), a Canadian pharmaceutical developer and marketer of high quality, cost-effective products for select health care markets, announced today that it has been issued a patent by the Japan Patent Office for one of its lead products, Uracyst® (a sterile sodium chondroitin sulfate solution, 2%) for the treatment of cystitis and other related conditions.

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